Effects of 'NHGDoc' on Quality of Care (NHGDoc)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
NHGDoc domain Heart Failure
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Computerized Decision Support System, Heart failure, Effects on quality of care, Process of care, Patient outcomes
Eligibility Criteria
Inclusion Criteria:
- General practices should use the information system MicroHIS X or Promedico ASP
- NHGDoc should be available in the general practices
Exclusion Criteria:
- General practices that do not meet the inclusion criteria
Sites / Locations
- Radboud University Nijmegen Medical Centre, IQ healthcare
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Active decision support
Passive decision support
Arm Description
Regular NHGDoc domains plus NHGDoc domain heart failure
Regular NHGDoc domains
Outcomes
Primary Outcome Measures
Prescribing of ACE-inhibitors/Angiotensin II
Percentage of patients with heart failure that is prescribed ACE-inhibitors/Angiotensin II
Prescribing of beta blockers
Percentage of heart failure patients that is prescribed beta blockers
Prescribing of diuretics
Percentage of heart failure patients that is prescribed diuretics
Secondary Outcome Measures
Hospital admissions
Number of hospital admissions of patients with heart failure
All cause mortality
Number of patients with heart failure that die within the hospital
Full Information
NCT ID
NCT01773057
First Posted
November 22, 2012
Last Updated
April 11, 2018
Sponsor
Radboud University Medical Center
Collaborators
Netherlands: Ministry of Health, Welfare and Sports
1. Study Identification
Unique Protocol Identification Number
NCT01773057
Brief Title
Effects of 'NHGDoc' on Quality of Care
Acronym
NHGDoc
Official Title
Effects of the Computerized Decision Support System 'NHGDoc' on Quality of Care: a Cluster Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Netherlands: Ministry of Health, Welfare and Sports
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether the computerized decision support system 'NHGDoc' is effective in improving quality of primary care in terms of processes of care (e.g. prescribing behavior of physicians) as well as outcomes of care (e.g. hospital admissions, mortality).
Detailed Description
Computerized decision support systems are regarded as useful tools to improve quality of care, but their effects are still uncertain. In the Netherlands 'NHGDoc' a computerized decision support system supported by the Dutch College of General Practitioners (NHG) is currently being implemented among more than 1.000 general practices in the Netherlands.
The aim of this study is to evaluate the effects of NHGDoc on quality of care. In addition, we want to gain insight into the barriers and facilitators that affect the systems' impact.
A cluster randomized controlled trial will be conducted among 120 general practices in the Netherlands. Eligible practices will be randomized to receive either the regular NHGDoc modules (control arm) or the regular modules and an additional module on heart failure (intervention arm). The effect evaluation will focus on processes of care (e.g. prescription behavior) as well as on patient outcomes (e.g. hospital admissions, mortality). Additionally, a process evaluation will be conducted, which includes a focus group study and a survey among participating healthcare providers to evaluate the perceived barriers and facilitators to using 'NHGDoc'.
Results of this study will provide insight in the ability of computerized decision support systems and in particular 'NHGDoc' to improve quality of primary care. Whereas the trial focuses on a specific NHGDoc domain - heart failure - we believe our conclusions are relevant to other primary care areas as well, particularly as this study also explores the factors that contribute to the systems' effectiveness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Computerized Decision Support System, Heart failure, Effects on quality of care, Process of care, Patient outcomes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active decision support
Arm Type
Experimental
Arm Description
Regular NHGDoc domains plus NHGDoc domain heart failure
Arm Title
Passive decision support
Arm Type
No Intervention
Arm Description
Regular NHGDoc domains
Intervention Type
Other
Intervention Name(s)
NHGDoc domain Heart Failure
Intervention Description
Healthcare providers receive patient specific alerts in terms of diagnosing and treatment of patients with heart failure
Primary Outcome Measure Information:
Title
Prescribing of ACE-inhibitors/Angiotensin II
Description
Percentage of patients with heart failure that is prescribed ACE-inhibitors/Angiotensin II
Time Frame
One year
Title
Prescribing of beta blockers
Description
Percentage of heart failure patients that is prescribed beta blockers
Time Frame
One year
Title
Prescribing of diuretics
Description
Percentage of heart failure patients that is prescribed diuretics
Time Frame
One year
Secondary Outcome Measure Information:
Title
Hospital admissions
Description
Number of hospital admissions of patients with heart failure
Time Frame
One year
Title
All cause mortality
Description
Number of patients with heart failure that die within the hospital
Time Frame
One year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
General practices should use the information system MicroHIS X or Promedico ASP
NHGDoc should be available in the general practices
Exclusion Criteria:
General practices that do not meet the inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tijn Kool, PhD
Organizational Affiliation
IQ healthcare, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Nijmegen Medical Centre, IQ healthcare
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
26474603
Citation
Lugtenberg M, Pasveer D, van der Weijden T, Westert GP, Kool RB. Exposure to and experiences with a computerized decision support intervention in primary care: results from a process evaluation. BMC Fam Pract. 2015 Oct 16;16:141. doi: 10.1186/s12875-015-0364-0.
Results Reference
derived
PubMed Identifier
25322766
Citation
Lugtenberg M, Westert GP, Pasveer D, van der Weijden T, Kool RB. Evaluating the uptake and effects of the computerized decision support system NHGDoc on quality of primary care: protocol for a large-scale cluster randomized controlled trial. Implement Sci. 2014 Oct 17;9:145. doi: 10.1186/s13012-014-0145-5.
Results Reference
derived
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Effects of 'NHGDoc' on Quality of Care
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